{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T10:31:23Z","timestamp":1740133883896,"version":"3.37.3"},"reference-count":38,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","award":["FDN-143347"],"award-info":[{"award-number":["FDN-143347"]}],"id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009326","name":"Cancer Research Society","doi-asserted-by":"publisher","award":["70302"],"award-info":[{"award-number":["70302"]}],"id":[{"id":"10.13039\/100009326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2024,5,25]]},"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Carrageenan-containing gels researched for the prevention of sexually transmitted infections (STIs) have shown promising results for human papillomavirus prevention in women, but not in men. We conducted a narrative review to assess the safety of these gels for genital use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We searched PubMed using MeSH terms and keywords on 5 November 2023. Title\/abstract of articles were screened to identify relevant ones. Full-text screening determined eligibility: empirical study evaluating safety of carrageenan-containing gel(s) for genital use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 125 identified records, 15 were eligible, comprising 14 (10 randomised controlled trials and 4 cohorts) unique study populations. Studies included women only (n=11), men only (n=1) or both (n=3); number of participants ranged from 4 to 6202. Safety was assessed for vaginal (n=13), penile (n=3) and anal use (n=2). Most studies assessed safety of Carraguard (53%), followed by Divine9 (14%), and one each of iota-carrageenan gel, lambda-carrageenan gel, Carvir, PC-6500 (griffithsin and carrageenan) and PC-1005 (MIV-150\/zinc acetate\/carrageenan). Safety assessment relied on self-report (80.0%), testing for STIs (53.3%), investigator-identified genital findings (93.3%) and\/or testing for changes in genital flora (60.0%). Adverse events (AEs) were described by investigators as mostly mild, (mostly) comparable between groups, not observed and\/or not significant for vaginal and penile use. Only one study, assessing anal use of carrageenan, reported a significantly higher proportion of AEs in the carrageenan compared with placebo group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Carrageenan-based gels are generally well tolerated for vaginal and penile, but not anal use. Studies on carrageenan gel\u2019s safety for anal use are scarce.<\/jats:p><\/jats:sec>","DOI":"10.1136\/sextrans-2024-056176","type":"journal-article","created":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T17:28:35Z","timestamp":1717781315000},"page":"388-394","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Safety of carrageenan-based gels as preventive microbicides: a narrative review"],"prefix":"10.1136","volume":"100","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7039-9999","authenticated-orcid":false,"given":"Cassandra","family":"Laurie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5190-0370","authenticated-orcid":false,"given":"Mariam","family":"El-Zein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4409-8084","authenticated-orcid":false,"given":"Eduardo L","family":"Franco","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,6,7]]},"reference":[{"key":"2024081910400988000_100.6.388.1","unstructured":"U.S. Food & Drug Administration . 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